Fat Grafting for Vaginal Stenosis in Gynaelogical Cancer

NCT ID: NCT06015360

Last Updated: 2023-10-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-31
• Study Completion Date: 2025-09-30

Brief Summary

The GRASS study looks at performing a technique called "Fat Tissue Grafting" to assess whether it can reduce the side effects of vaginal stenosis effects and improve the sexual function of participants who wish to preserve penetrative sexual function

Detailed Description

Vaginal stenosis is a common sequelae of radiotherapy treatment for cervical cancer. This can cause significant sexual problems resulting in sexual avoidance, relationship problems, feelings of low self-esteem, isolation, and difficulties initiating new relationships. Vaginal changes resulting in narrowing (stenosis) and adhesions can also lead to painful vaginal examinations which are routinely performed during follow-up consultations.

The available treatments for vaginal problems include regular use of vaginal dilators, lubricants, and moisturisers, all of which have shown poor results despite requiring an incessant effort by women.

A technique called 'fat grafting' has been successfully and safely used for many years to rectify the cosmetic and functional consequences of Breast and Head and Neck Cancers treatments. This technique is performed under general anaesthesia and uses fat tissue that is removed from other parts of the body; usually thighs, abdomen, and buttocks, by liposuction. The fat tissue is then processed into liquid and injected into the required area to generate more elasticity and improve tissue quality. To our knowledge this technique has never been applied to the field of Gynaecology-oncology.

In 2021 this technique was used in one patient with severe vaginal stenosis after radiotherapy treatment for advanced cervical cancer, by the Gynaecological and Plastic surgical teams at the Royal Marsden Hospital (RM). The fat tissue was harvested and processed using the method as described and injected into the vagina area (rectovaginal wall) with the aim being to generate more elasticity and improve the quality of the vaginal tissue. As a result of the procedure, the patient now reports reduction in vaginal bleeding and pain experienced, and a noticeable improvement in the size of the vagina allowing for penetrative sex.

This innovative technique addresses a neglected and unmet need of women to manage a consequence of curative treatment that is underreported and often unrecognised. It also serves as an example of how cross-discipline work focused on real patients' needs can produce ground-breaking solutions to complex clinical conundrums, by mobilising highly specialist clinical experts.

If this programme is successful, it can be expanded to women with vaginal stenosis due to radiotherapy for other cancers e.g., colorectal, or urological cancer. In addition, the investigators the investigators will work in partnership with the patient(s) who successfully benefit from fat grafting treatment to guide the development of a larger study.

Conditions

Cervical Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fat Grafting

The fat grafting procedure will be conducted as per local standard RM protocol. All procedures will be conducted by the study Principal Investigator (PI) who is well practiced in performing this procedure in Head \& Neck and breast cancer patients and also in scar revision patients.

Group Type: EXPERIMENTAL

Fat Graft

Intervention Type: PROCEDURE

Fat grafting

Interventions

Fat Graft

Fat grafting

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients with cervical cancer
• At least 2 years since finishing pelvic radiotherapy for gynaecological cancer
• Treated at RM
• Persistent symptoms of vaginal stenosis despite prior use of vaginal dilators/ oestrogen replacement / lubricants/moisturisers
• Desiring vaginal intercourse

Exclusion Criteria

• Evidence of recurrent disease documented on Magnetic Resonance Imaging (MRI)
• Patients unwilling / unable to provide written informed consent for the study

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Royal Marsden NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Royal Marsden NHS Foundation Trust

London, , United Kingdom

Countries

United Kingdom

Facility Contacts

Mark Brandon-Grove

Role: primary

Mark.Brandon-Grove@rmh.nhs.uk

02031865416

Other Identifiers

CCR5742

Identifier Type: -

Identifier Source: org_study_id